BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7144159 · Received December 22, 2017

    Report

    Report Number
    1213809-2017-00388
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    December 4, 2017
    Report Date
    March 8, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ONE SEALED SHELF CARTON OF 200 SEALED PACKAGED SYRINGES AND 99 SEALED PACKAGED SYRINGES WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCH # 7150632 (P/N 302995). 16 SYRINGES WERE RANDOMLY SELECTED FOR FURTHER EVALUATION. THESE 16 SYRINGES WERE REMOVED FROM PACKAGING TO BETTER PERFORM VISUAL INSPECTION. NO FOREIGN MATTER WAS OBSERVED INSIDE OR OUTSIDE OF THE SYRINGES. A DEVICE HISTORY RECORD (DHR) REVIEW FOR BATCH 7150632 (P/N 302995) WAS PERFORMED, ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7150632 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. NO ROOT CAUSE CAN BE DETERMINED AS NO DEFECTS WERE CONFIRMED. CAPA IS NOT REQUIRED AS NO DEFECTS WERE CONFIRMED. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD SYRINGE LUER-LOK¿ TIP WAS FOUND WITH BLACK SPECS FLOATING IN THE SYRINGE. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923765 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7150632 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other